A comparison of efficacy and saftey of fractional spinal anaesthesia versus conventional spinal anaesthesia with 0.5 percent hyperbaric bupivacaine and fentanyl in patients undergoing infra umbilical and lower limb surgeries.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. To compare the intra-operative hemodynamic changes in fractional spinal anaesthesia and
研究概览
简要总结
Spinal anaesthesia is usually performed anaesthesia technique for infraumbilical and lower limb surgeries. It provides sensory as well as motor blockade. Spinal anaesthesia continues to dominate the field of anaesthesiology because of its rapid onset, simplicity and low complications compared to general anaesthesia. Multiple local anaesthetic agents were used over a period of time. Hyperbaric Bupivacaine 0.5% being the most used one due to its longer duration of action and addition of adjuvant further increased the duration of spinal anaesthesia. Different adjuvants cause different changes in hemodynamic parameters, sensory blockade, motor blockade and analgesia. Fentanyl is a synthetic opioid drug, which is most commonly added as an adjuvant in intrathecal injection because it is more potent, providing better analgesia, hemodynamic stability with better safety profile.
Spinal anaesthesia causes a sympathetic denervation resulting in hypotension because of the rapid sympathetic block.In the conventional technique of spinal anaesthesia bolus dose of drug which many a times gives higher level of anaesthesia than the desired, thus causes more hypotension. In comparison to this, if the drug is administered in two or more divided doses (fractionated doses) in the subarachnoid space rather than entire dose being injected as one dose, occurence of hypotension is reduced.
Fractional spinal anaesthesia technique has been recently introduced. In fractional technique of spinal anaesthesia, after giving 1st fractionated dose , the drug will settle down as the patient to be kept in sitting position for 30-90 seconds, so desired and predicted sensory and motor blockade to be achieved. Then after 2nd fractionated dose is injected and after giving 2nd fractionated dose the patient to be made supine which leads to slow distribution of the drug which prevents hypotention and provides better hemodynamic stability. Fractional spinal anaesthesia is used for a number of surgical procedures because of more hemodynamic stability, longer duration of sensory and motor blockade and longer duration of analgesia in camparison to conventional spinal anaesthesia.
Few studies have been done and published comparing both of these techniques, fractional v/s conventional spinal anaesthesia. Both of these techniques of spinal anaesthesia are used interchangeably in our institute. But, the data collection on comparing both of these techniques has not been done previously. The data being collected from this study, might be helpful for establishing some beneficial and advanced/recent protocol in the anaesthesia department, thereby to the institute and anaesthesia society also. So, the present study will be conducted to compare the efficacy and safety of fractional spinal anaesthesia v/s conventional spinal anaethesia using hyperbaric bupivacaine 0.5% (3ml–15mg) as a local anaesthetic and fentanyl (0.5ml-25mcg) as an adjuvant in patients of infraumbilical and lower limb surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •American Society of Anaesthesiology (ASA) Grade I & II weight: 50 – 80 Kgs.
- •height: 150 – 170 cms Patients posted for infra-umbilical and lower limb surgery.
排除标准
- •Patient refusal for study Patient with clinically significant Coagulopathy Patient with spine deformities Patients with infection at site of Spinal Injection Patients with associated systemic diseases e.g. hypertension, diabetes mellitus, kidney diseases, respiratory diseases, cardiovascular diseases, liver disease.
- •Patients with history of allergy to local anaesthetics and opioids Pregnant and lactating females Patients who have history of drug abuse Psychologically challenged patients Non cooperative patient.
结局指标
主要结局
1. To compare the intra-operative hemodynamic changes in fractional spinal anaesthesia and
时间窗: 2 years
conventional spinal anaesthesia (Heart Rate, Systolic blood pressure, Diastolic blood pressure, Mean
时间窗: 2 years
Arterial Blood Pressure, SpO2%).
时间窗: 2 years
2. To compare the sensory blockade parameters (time of onset of sensory blockade, time of peak
时间窗: 2 years
level of sensory blockage and duration of sensory blockade) between fractional spinal anaesthesia and
时间窗: 2 years
conventional spinal anaesthesia.
时间窗: 2 years
3. To compare the motor blockade parameters (time of onset of motor blockade, duration of motor
时间窗: 2 years
blockade) between fractional spinal anaesthesia and conventional spinal anaesthesia .
时间窗: 2 years
4. To compare the duration of analgesia between fractional spinal anaesthesia and conventional
时间窗: 2 years
spinal anaesthesia.
时间窗: 2 years
次要结局
- To study side effects in patients undergoing fractional spinal anaesthesia and conventional spinal(anaesthesia.)
研究者
DR SHREYA VEKARIYA
GMERS MEDICAL COLLEGE AND HOSPITAL
